FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
“On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The regulatory decision was supported by data from the phase 2/3 QUILT-3.032 trial (NCT0302285), which demonstrated that patients treated with the combination (n = 77) experienced a complete response (CR) rate of 62% (95% CI, 51%-73%). Additionally, 58% of patients who achieved a CR had a duration of response (DOR) of at least 12 months, and 40% of patients with a CR had a DOR of at least 24 months.”
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